STA R MAX

K151867 · Diagnostica Stago S.A.S · JPA · Aug 7, 2015 · Hematology

Device Facts

• Record ID: K151867
• Device Name: STA R MAX
• Applicant: Diagnostica Stago S.A.S
• Product Code: JPA · Hematology
• Decision Date: Aug 7, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The STA R Max® is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Device Story

STA R Max is an automated hemostasis analyzer for clinical laboratory use. It processes patient samples to perform coagulation testing using chronometric and photometric detection methods. Modifications from the predicate (STA-R Evolution Expert Series) include a new graphical user interface (GUI), updated external design (color, shape, ergonomics), a new computer table, and enhanced communication protocols for Laboratory Information System (LIS) or middleware integration. The device utilizes an integrated PC with updated microprocessor, memory, and hard disk specifications. It maintains the same fundamental scientific technology as the predicate, including coagulation detection methods, barcode identification for samples/reagents, and disposables. The system is operated by laboratory personnel to provide diagnostic data for clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, risk assessment, and verification/validation activities confirming that modifications to the predicate device do not affect safety or effectiveness.

Technological Characteristics

Fully automatic coagulation analyzer. Detection: chronometric (inductive sensors measuring metal ball oscillation) and photometric (tungsten-halogen lamp, 405/540 nm filters, optical fibers). Materials: standard laboratory cuvettes. Connectivity: RS232, USB, RJ45. Electrical safety: IEC 61010-2-101:2003. Software: embedded system with GUI and LIS communication protocols.

Indications for Use

Indicated for use in hospital or healthcare laboratories to perform in vitro coagulation tests on human plasma to aid in the diagnosis of coagulation abnormalities or monitoring of anticoagulant therapy in patients.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• STA-R Evolution® Expert Series (K093001)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, featuring three human profiles facing right, suggesting a sense of community and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 20, 2015

Diagnostica Stago, Inc. James Monroe Regulatory Project Manager 5 Century Drive Parsippany, NJ 07054

Re: K151867

Trade/Device Name: STA R Max® Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: June 29, 2015 Received: July 10, 2015

Dear Mr. Monroe:

This letter corrects our substantially equivalent letter of August 7, 2015.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

Device Name STA R Max®

Indications for Use (Describe)

The STA R Max® is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/14 description: The image features the logo for Stago, a company specializing in in-vitro diagnostics. The logo consists of the word "Stago" in a serif font, with the "S" capitalized and the rest of the letters in lowercase. Above the word "Stago" is an abstract graphic element, featuring a red shape resembling a stylized flame or leaf, positioned next to a gray teardrop shape. The overall design is clean and professional, reflecting the company's focus on healthcare and diagnostics.

### Attachment_09

## 510(k) Summary

## STA R Max®

| | A. 510(k) Submitter information | |
|----|-----------------------------------------|--|
| | B. Device Information | |
| | C. Predicate Device Information | |
| | D. Indication/Intended Use | |
| | E. Purpose of the Special 510(k) Notice | |
| | F. Description of the device | |
| 1) | Principles of Operation | |
| 2) | Fundamental technologies | |
| | G. Substantial Equivalence | |

### A. 510(k) Submitter information

| Submitter's name | Diagnostica STAGO S.A.S |
|---------------------|-------------------------|
| | 125 Avenue Louis Roche |
| Address | 92230 Gennevilliers |
| | France |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Date of Preparation | 06/29/2015 |

### Application Correspondent and Contact Person information

| Name | James Monroe |
|--------------|-------------------------------------------------|
| Address | 5 Century Drive<br>Parsippany, New Jersey 07054 |
| Phone Number | [phone] x 4306 |
| Fax Number | [phone] |

This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization

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### B. Device Information

| Device Trade Name | STA R Max®. |
|----------------------------|------------------------------------------------------------------------------------------------------------------|
| Device Common Name | IVD Coagulation Device/Instrument<br>Automated and Semi-Automated Hematology device<br>Multi-Parametric Analyzer |
| Device Classification Name | System, Multipurpose for In Vitro Coagulation Studies |
| Regulatory Class | Class II |
| Panel | Part 864 - Hematology and Pathology Devices |
| Product Code | JPA |
| Regulation Number | 864.5425 |

| Picture 1: STA R Max® | |
|-----------------------|--|
|-----------------------|--|

Image /page/4/Picture/6 description: The image shows a large, automated laboratory analyzer and a computer workstation. The analyzer is white and gray with a blue-tinted window, and it has a sample loading area on the left side. The computer workstation includes a monitor, keyboard, mouse, and barcode scanner, all mounted on a rolling stand. The analyzer is likely used for high-throughput clinical chemistry or immunoassay testing.

### C. Predicate Device Information

| 510(k) Number | K093001 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | STA-R Evolution® Expert Series |
| Device Common Name | STA-R Evolution® Expert Series<br>IVD Coagulation Device/Instrument Automated and<br>Semi-Automated Hematology device Multi-<br>Parametric Analyzer |
| Device Classification Name | System, Multipurpose for In Vitro Coagulation Studies |
| Regulatory Class | Class II |
| Panel | Part 864 - Hematology and Pathology Devices |
| Product Code | JPA |
| Regulation Number | 864.5425 |

This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization

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Image /page/5/Picture/3 description: The image shows a STA-R Evolution Expert Series machine, identified by the code (K093001). It features a monitor at the top, displaying a graphical user interface with various icons and data points. The machine has a modular design with different sections, including a sample loading area and a processing unit, all mounted on wheels for mobility.

# Picture 2: STA-R Evolution® Expert Series

## D. Indication/Intended Use

The STA R Max® is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

## E. Purnose of the Snecial 510(k) Notice

The STA R Max® is a modification to the company's own legally marketed device, STA-R Evolution® Expert Series (K093001).

The modifications of the device involve:

- Implementation of a new graphical user interface (GUI) to use the graphical chart -1of Max line of STA Analyzers.

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- -2-Changes to the external design (colors and shape) of the analyzer which include modifications of the openings and the addition of a new computer table for improved ergonomics.
- -3-Improvement of the communication protocol with a LIS or a middleware so more information can be exchanged.

### F. Description of the device

Diagnostica Stago's STA R Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA-R Evolution® Expert Series analyzer (K093001). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment.

The device consists of the following components:

- -1a cuvette, which holds the patient sample and any needed reagent;
- -2a metal ball located in the cuvette, that is induced to oscillate to measure coagulation;
- three needles that will aspirate and dispense the patient's sample and reagents into -3the cuvette:
- -4oscillation amplitude detection of a metal ball in a cuvette to measure sample coagulation by the chronometric method;
- -2a light source and sensor to transmit light through the cuvette containing the sample and reagents that subsequently measures the light absorbed as a reaction takes place;
- Software which conducts the measurement and test determination; -6-

### Principles of Operation 1)

The principles of operation are the same as described for STA -R Evolution® Expert Series (predicate device) in submission, K093001. A brief summary follows:

- > The STA R Max® is designed as a fully automatic system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, system supervision, support for instrument maintenance, and workload optimization.
- > The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators and controls

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facilitate their use on the system and facilitates reagent management. Manual entry of reagent information enables the use of non-barcoded-reagents.

- > There are two methods used by the instrument to measure coagulation: the chronometric (clotting time or clot-based measurements) and photometric assays (at specific wave lengths) on plasma samples.
### 2) Fundamental technologies

The Technological characteristics are the same for the STA R Max® and the STA-R Evolution® Expert Series

### ● Chronometry Measurement Principle

The principle consists in measuring the variations of the ball oscillation amplitude through inductive sensors. The ball has a pendular movement obtained:

- due to the two curved rail tracks in the bottom of the cuvettes
- and an alternating electromagnetic field generated by two independent drive coils.

The oscillation amplitude is constant when the viscosity of the medium through which the ball moves remains constant.

The oscillation amplitude decreases when the viscosity of this medium increases as shown in Schema 1.

Image /page/7/Figure/13 description: The image shows a diagram of a ball oscillating in a container, along with a graph of the amplitude of the ball's oscillation over time. The graph shows that the amplitude of the ball's oscillation decreases over time, eventually leading to clotting. The x-axis of the graph is labeled "Amplitude of the ball oscillation", and the y-axis is labeled "T".

Schema 1: Amplitude of the ball oscillation during clotting

- Photometry Measurement Principle
The detection principle for chromogenic or immunological analyses on the STA R Max® is based on the absorbance (optical density, O.D.) of monochromatic (405 nm or 540 nm) light passing through a cuvette as an enzymatic or immunological reaction takes place.

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The principle underlying the measurement of absorbance is depicted in the Schema 2 below:

Image /page/8/Figure/4 description: The image contains the text "Schema 2: Measurement principle of absorbance". The text appears to be a title or heading, possibly indicating the subject matter of a diagram or explanation related to the measurement principle of absorbance. The text is written in a formal font.

Image /page/8/Picture/5 description: The image shows a diagram of a container with liquid and arrows indicating light intensity. The arrows are labeled I0, Ip, and I1=I+Ip, representing different light intensities. In the upper right corner, there is a table showing DO values with corresponding numbers 0, 1, and 2, and values of 1, 1.0, and 100.

Incident light (lo) entering the cuvette is partially absorbed by the reaction medium as it passes through.

The transmitted light (I1 = I + Ip) is measured.

The effect of stray light (lo) is eliminated by taking two measurements of transmitted light within a brief interval:

I1 = I + In (first measurement which includes incident light and stray light)

I2 = Io (second measurement, while blocking incident light, corresponds to the stray light)

l2 is subtracted from 11 to obtain I, which corresponds to light resulting only from incident light. Stray light (In) is assumed to remain constant between the two measurements.

The absorbance is calculated using the following equation: A = -log(I/Io) note: log decimal

Monochromatic incident light (lo) is produced by passing light from a tungstenhalogen lamp through a 405 nm or 540 nm monochromatic filter, placed in a mobile filter holder.

These parts are located inside the optical module. The monochromatic light is directed from the optical module to the measurement heads by optical fibers, then another set of optical fibers carries the light from the measurement heads to the photometry measurement board.

This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization

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### G. Substantial Equivalence

The STA R Max® and its Predicate Device, STA-R Evolution® Expert Series (K093001) have the same Indications for Use, Technology, Principles of Operation and comparable Performances as described in Table 1.

| | Table 1. Substantial Equivalence Comparison | |
|--|---------------------------------------------|--|
| | | |

| Characteristics<br>or Attributes | Diagnostica Stago,<br>STA R Max® | Diagnostica Stago,<br>STA-R Evolution®<br>Expert Series | Identical/<br>Different | |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------|
| 510(k) number | 510(k) subject device | K093001 | N/A | |
| Indications for<br>Use/Intended<br>Use | The STA R Max® is a fully<br>automatic clinical instrument<br>indicated and intended for the<br>performance of tests on<br>human plasmas, the results of<br>which aid in the diagnosis of<br>coagulation abnormalities or<br>in monitoring anticoagulant<br>therapy. | The STA-R Evolution®<br>Expert Series is a fully<br>automatic clinical<br>instrument indicated<br>and intended for the<br>performance of tests on<br>human plasmas, the<br>results of which aid in<br>the diagnosis of<br>coagulation<br>abnormalities or in<br>monitoring<br>anticoagulant therapy. | Identical | |
| Target<br>Population | To aid in the diagnosis of<br>coagulation abnormalities or<br>in monitoring anticoagulant<br>therapy in patients. | To aid in the diagnosis<br>of coagulation<br>abnormalities or in<br>monitoring<br>anticoagulant therapy<br>in patients. | Identical | |
| Anatomical<br>Sites | In vitro testing of human<br>plasma | In vitro testing of<br>human plasma | Identical | |
| Point of use | Hospital Laboratory or other<br>Health Care Laboratory. | Hospital Laboratory or<br>other Health Care<br>Laboratory. | Identical | |
| Chronometric<br>Method of<br>Coagulation<br>Detection | Mechanical measurement of<br>the oscillation of the metal<br>ball in the cuvette. | Mechanical<br>measurement of the<br>oscillation of the metal<br>ball in the cuvette. | Identical | |
| Photometric<br>method of<br>Coagulation<br>Detection | Light absorption technique<br>provided by a filtered light<br>source (405μm, 540μm). | Light absorption<br>technique provided by<br>a filtered light source<br>(405μm, 540μm). | Identical | |
| Characteristics<br>or Attributes | Diagnostica<br>Stago, STA R<br>Max® | Diagnostica Stago,<br>STA-R Evolution®<br>Expert Series | Identical/<br>Different | |
| Electrical Safety | UL Listed.<br>+ IEC 61010-2-<br>101:2003 - Safety<br>requirements for<br>electrical equipment for<br>measurement, control<br>and laboratory use –<br>Part 2-101: Particular<br>requirements for in<br>vitro diagnostic (IVD)<br>medical equipment. | UL Listed.<br>+ IEC 61010-2-<br>101:2003 - Safety<br>requirements for<br>electrical equipment for<br>measurement, control<br>and laboratory use –<br>Part 2-101: Particular<br>requirements for in vitro<br>diagnostic (IVD)<br>medical equipment. | Identical | |
| Dimensions | Height | 1265 mm | 1250 mm | Different |
| | Width | 1220 mm | 1280 mm | Different |
| | Depth | 805 mm | 820 mm | Different |
| Integrated<br>PC | µproces<br>sor | Intel Celeron M423<br>1.06 GHz | Pentium MMX<br>(200MHz Min) | Different |
| | Memor<br>y | 1 GB | 64Mb (Min) | Different |
| | Hard<br>disk | 80 GB | 2.4 GB (Min) | Different |
| Weight | | 238 kg | 226 kg | Different |
| Barcode ID of samples and<br>reagents | | Yes | Yes | Identical |
| Connections | | RS232, USB, RJ45 | RS232 | Different |
| Disk | | None (external USB<br>CD/DVD optional) | CD/DVD recorder,<br>floppy disk | Different |
| Computer table | | Yes (with 6 x 2.0<br>USB ports to connect<br>the following USB<br>peripheral devices:<br>keyboard, mouse,<br>touchscreen, printer,<br>USB flash drive) | Yes (unconnected) | Different |
| Touch Screen | | Yes | Yes (optional) | Different |
| Disposables | | identical | identical | Identical |

This document is property of DIAGNOSTICA STAGO. It cannot be communicated or copied without any prior authorization

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Image /page/10/Picture/1 description: The image shows the logo for Stago, a company that specializes in in-vitro diagnostics. The logo features the company name "Stago" in a serif font, with the "S" slightly larger than the other letters. Above the name is an abstract graphic element in two colors: red and gray. The red portion is shaped like a curved triangle, while the gray portion resembles a crescent shape.

Comparison between the predicate and subject devices have minor differences. The differences are a result of the obsolescence of computer peripherals such as floppy discs, computer processors, and the addition of the new graphic interface and evolution of the communication protocol have no impact on performance, principle of operation, or

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Image /page/11/Picture/1 description: The image shows the logo for Stago. The logo features the word "Stago" in a red, serif font. Above the word is a stylized graphic element that resembles two overlapping shapes, one red and one gray. The red shape is positioned slightly above and to the left of the gray shape, creating a sense of depth.

fundamental technology. The modifications of external design (e.g. color, weight, dimension, and shape) are ergonomic and cosmetic enhancements, which neither affect the fundamental technology, nor raise any new questions of safety and effectiveness. Thus the two devices are substantially equivalent with respect to their key attributes.

### Conclusion

The STA R Max® and its Predicate Device, STA-R Evolution® Expert Series (K093001), have the same Intended Use/Indications for Use, same fundamental technology, same principles of operation, and comparable performance characteristics. The modifications consist of changes to the software (to integrate a new graphical user interface and a new communication protocol), new peripherals, and new external shape (for ergonomic improvements).

As evidenced by risk assessment and verification and validation activities, no new questions of safety and effectiveness were raised. Therefore we believe, the STA R Max® is substantially equivalent to the STA-R Evolution® Expert Series (K093001) predicate device.